Investigating left bundle branch area pacing for heart failure patients
Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal
This study is testing a new pacing technique for heart failure patients with weak heart function to see if it can help them feel better when other treatments haven’t worked.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT06148571 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of left bundle branch area pacing in patients with heart failure who have a left ventricular ejection fraction of 50% or less. It addresses the limitations of traditional cardiac resynchronization therapy, particularly in patients with unfavorable coronary anatomy. By creating a registry, the study seeks to gather concrete evidence on the potential benefits of this pacing technique as a rescue therapy for patients who have not responded to standard treatments.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with heart failure and a left ventricular ejection fraction of 50% or less who require cardiac pacing.
Not a fit: Patients who are under 19 years old, pregnant, or have a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for heart failure patients who are not candidates for conventional pacing methods.
How similar studies have performed: While the efficacy of left bundle branch area pacing is largely hypothetical, there is a growing interest in its potential, though concrete evidence from similar studies is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients previously diagnosed with heart failure with mid-range(or mildly reduced) ejection fraction and heart failure with reduced ejection fraction, which was documented by an appropriate echocardiographic study (Left ventricle ejection fraction \<50%), and * Patients with indications of cardiac pacing or cardiac resynchronization therapy Exclusion Criteria: * Patients aged less than 19 years. * Pregnant. * Patients with an expected life expectancy of less than 1 year. * Patients with a mechanical valve for the tricuspid valve. * Patients who need atrial pacing only. * Patients who are not capable of receiving a transvenous pacemaker for any reason.
Where this trial is running
Seoul, Jongno-gu
- Seoul National University Hospital — Seoul, Jongno-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Eue-Keun Choi, M.D. Ph.D. — Seoul National University Hospital
- Study coordinator: Eue-Keun Choi, M.D. Ph.D.
- Email: choiek417@gmail.com
- Phone: 82-2-2072-0688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.